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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device rod, fixation, intramedullary and accessories
Regulation Description Intramedullary fixation rod.
Product CodeHSB
Regulation Number 888.3020
Device Class 2


Premarket Reviews
ManufacturerDecision
ADAPTABLE ORTHO INNOVATIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 5
BAAT MEDICAL PRODUCTS B.V.
  SUBSTANTIALLY EQUIVALENT 1
CHANGZHOU GEASURE MEDICAL APPARATUS AND INSTRUMENTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CITIEFFE S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
CONVENTUS ORTHOPAEDICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
DEPUY SYNTHES
  SUBSTANTIALLY EQUIVALENT 1
DOUBLE MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
FH INDUSTRIE
  SUBSTANTIALLY EQUIVALENT 1
FLOW-FX, LLC
  SUBSTANTIALLY EQUIVALENT 2
FLOWER ORTHOPEDICS CORPORATION DBA CONVENTUS FLOWER
  SUBSTANTIALLY EQUIVALENT 2
FUSION ORTHOPEDICS USA, LLC
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
GLW, INC.
  SUBSTANTIALLY EQUIVALENT 2
GM DOS REIS INDUSTRIA E COMERCIO
  SUBSTANTIALLY EQUIVALENT 1
GPC MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1
I.T.S. GMBH
  SUBSTANTIALLY EQUIVALENT 1
INNOSYS
  SUBSTANTIALLY EQUIVALENT 1
INTRAUMA S.P.A
  SUBSTANTIALLY EQUIVALENT 1
JEIL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
MEDSHAPE, INC.
  SUBSTANTIALLY EQUIVALENT 1
NEOORTHO PRODUTOS ORTOPÉDICOS S/A
  SUBSTANTIALLY EQUIVALENT 1
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 7
NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
ORTHO DEVELOPMENT CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ORTHO SOLUTIONS UK , LTD.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX SRL
  SUBSTANTIALLY EQUIVALENT 5
ORTHOPEDIATRICS CANADA ULC DBA PEGA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPEDIATRICS CORP.
  SUBSTANTIALLY EQUIVALENT 3
ORTHOPEDIC DESIGNS NORTH AMERICA, INC. (ODI-NA)
  SUBSTANTIALLY EQUIVALENT 1
ORTHOXEL DAC
  SUBSTANTIALLY EQUIVALENT 1
PARAGON 28, INC.
  SUBSTANTIALLY EQUIVALENT 6
PEGA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
RESELUTE, INC.
  SUBSTANTIALLY EQUIVALENT 1
SATORI ORTHOPAEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 2
STRYKER GMBH
  SUBSTANTIALLY EQUIVALENT 8
STRYKER TRAUMA GMBH
  SUBSTANTIALLY EQUIVALENT 2
SYNTEC SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES (USA) PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 1
TDM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TORNIER, INC.
  SUBSTANTIALLY EQUIVALENT 1
VILEX, LLC
  SUBSTANTIALLY EQUIVALENT 1
WITTENSTEIN INTENS GMBH
  SUBSTANTIALLY EQUIVALENT 1
X-BOLT ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER GMBH
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER SWITZERLAND MANUFACTURING GMBH
  SUBSTANTIALLY EQUIVALENT 2
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2020 3299 3300
2021 4111 4129
2022 2733 2839
2023 2219 2240
2024 2869 2891
2025 2933 2994
2026 747 747

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 6408 6522
Break 3741 3774
Device-Device Incompatibility 2369 2383
Migration 2029 2043
Fracture 1605 1620
Material Twisted/Bent 421 425
Failure to Align 321 322
Material Deformation 317 318
Migration or Expulsion of Device 296 300
Mechanical Problem 216 216
Positioning Failure 181 181
Mechanical Jam 177 178
Patient Device Interaction Problem 162 163
Malposition of Device 154 154
Separation Problem 138 144
Use of Device Problem 128 128
Detachment of Device or Device Component 122 125
Connection Problem 106 106
Crack 105 105
Defective Device 103 103
Device Dislodged or Dislocated 103 103
Corroded 102 102
No Apparent Adverse Event 95 95
Physical Resistance/Sticking 91 91
Failure to Advance 91 91
Loosening of Implant Not Related to Bone-Ingrowth 76 86
Appropriate Term/Code Not Available 74 74
Difficult to Advance 73 74
Insufficient Information 71 79
Material Integrity Problem 68 68
Device Difficult to Setup or Prepare 58 58
Manufacturing, Packaging or Shipping Problem 56 56
Device Damaged by Another Device 55 55
Naturally Worn 52 52
Material Discolored 50 50
Device Slipped 45 45
Improper or Incorrect Procedure or Method 45 45
Entrapment of Device 43 43
Material Fragmentation 41 41
Contamination /Decontamination Problem 39 39
Loose or Intermittent Connection 33 33
Difficult to Remove 33 34
Incomplete or Inadequate Connection 32 32
Difficult to Insert 29 29
Separation Failure 27 27
Unintended Movement 26 26
Positioning Problem 25 25
Deformation Due to Compressive Stress 25 25
Tear, Rip or Hole in Device Packaging 25 25
Inadequacy of Device Shape and/or Size 24 36

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5581 5622
Failure of Implant 2490 2519
Non-union Bone Fracture 1867 1934
Insufficient Information 1794 1825
Pain 1447 1470
Limb Fracture 1400 1400
Bone Fracture(s) 826 828
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 777 786
No Code Available 749 749
Implant Pain 609 620
Unspecified Infection 441 446
Injury 423 423
Post Operative Wound Infection 410 410
No Consequences Or Impact To Patient 384 385
Foreign Body In Patient 244 244
No Known Impact Or Consequence To Patient 234 234
Malunion of Bone 230 230
Impaired Healing 223 226
Physical Asymmetry 219 223
Perforation 207 207
Necrosis 192 198
Unspecified Tissue Injury 175 175
Hip Fracture 168 169
No Patient Involvement 143 143
Ambulation Difficulties 131 135
Loss of Range of Motion 129 136
Fall 128 129
Discomfort 99 100
Osteolysis 94 94
Hematoma 89 90
Swelling/ Edema 66 66
Inflammation 63 65
Wound Dehiscence 55 55
Thrombosis/Thrombus 54 54
Post Traumatic Wound Infection 50 50
Nerve Damage 49 50
Hypersensitivity/Allergic reaction 49 49
Deformity/ Disfigurement 49 50
No Information 43 43
Ossification 42 42
Arthritis 38 38
Device Embedded In Tissue or Plaque 37 38
Joint Dislocation 28 28
Unequal Limb Length 27 27
Hemorrhage/Bleeding 27 27
Skin Inflammation/ Irritation 25 25
Muscle/Tendon Damage 25 25
Osteopenia/ Osteoporosis 24 24
Joint Laxity 23 23
Metal Related Pathology 22 23

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Jan-27-2023
2 Biomet, Inc. II Dec-17-2020
3 Flower Orthopedics Corporation II Oct-06-2023
4 Flower Orthopedics Corporation II Jan-03-2022
5 Merete Medical GmbH II Nov-06-2020
6 NuVasive Specialized Orthopedics, Inc. II Nov-21-2024
7 NuVasive Specialized Orthopedics, Inc. II Dec-01-2021
8 Nuvasive Specialized Orthopedics Inc II Apr-05-2021
9 Nuvasive Specialized Orthopedics Inc II Mar-30-2021
10 Nuvasive Specialized Orthopedics Inc II Oct-07-2020
11 Orthofix Srl II Jun-13-2025
12 Paragon 28, Inc. II Dec-02-2025
13 Paragon 28, Inc. II Mar-05-2024
14 Smith & Nephew, Inc. II May-19-2025
15 Smith & Nephew, Inc. II Aug-22-2023
16 Stryker GmbH II Jun-10-2025
17 Stryker GmbH II Jun-06-2025
18 Stryker GmbH II Jul-30-2021
19 Stryker GmbH II Jun-16-2020
20 Synthes (USA) Products LLC II Mar-01-2024
21 Synthes (USA) Products LLC II Mar-10-2023
22 Zimmer GmbH II Jun-04-2021
23 Zimmer, Inc. II Dec-22-2025
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